One-part dental compositions and methods for bleaching and desensitizing teeth

ABSTRACT

Composition and methods that include potassium nitrate for whitening and/or reducing tooth sensitivity. The dental compositions may optionally include a dental bleaching agent, such as hydrogen peroxide or carbamide peroxide. The dental compositions may be applied directly to the person&#39;s teeth, or they may be loaded into a comfortable fitting, flexible, thin-walled dental tray and placed over the person&#39;s teeth. In that case, the dental compositions will include a tackifying agent, such as carboxypolymethylene, dispersed within a solvent, which assists the composition in retaining the dental tray over the person&#39;s teeth as a result of the adhesive properties of the dental composition rather than due to mechanical interlocking of the tray over the person&#39;s teeth. The dental compositions may further include anticariogenic and antimicrobial agents.

BACKGROUND

1. The Field of the Invention

The present invention relates to compositions and methods for whiteningand desensitizing teeth. The present invention relates to compositionsthat may be applied directly to a person's teeth for shorter periods oftime, and those specifically formulated for use with flexible,thin-walled dental trays in order to provide prolonged treatment of apatient's teeth over longer periods of time.

2. The Relevant Technology

The use of certain foods and tobacco, the process of aging, diseases,trauma, medications, some congenital conditions, and environmentaleffects can cause teeth to become discolored. Because teeth withoutdiscolorations are usually considered to be aesthetically superior tostained or discolored teeth, there has been a heightened level ofinterest of late in developing compositions and methods for bleachingteeth.

A tooth is comprised of an inner dentin layer and an outer hard enamellayer that is slightly porous. The outer layer is the protective layerof the tooth. The natural color of the tooth is opaque to translucentwhite or slightly off-white.

Some dental compositions like dentrifices, toothpastes, gels, andpowders contain active oxygen or hydrogen peroxide liberating bleachingagents. Such bleaching agents include peroxides, percarbonates andperborates of the alkali and alkaline earth metals or complex compoundscontaining hydrogen peroxide. Also, peroxide salts of the alkali oralkaline earth metals are known to be useful in whitening teeth.

The most commonly used dental bleaching agent is carbamide peroxide(CO(NH₂)₂.H₂O₂), also called urea hydrogen peroxide, hydrogen peroxidecarbamide, and perhydrol-urea. Carbamide peroxide has been used bydental clinicians for several decades as an oral antiseptic. Toothbleaching was an observed side effect of extended contact time.Over-the-counter compositions of 10% carbamide peroxide are available asGLY-OXIDE® by Marion Laboratories and PROXIGEL® by Reed and Carnrick. Ableaching gel which is able to hold a comfortable-fitting dental tray inposition for an extended time period is available under the trademarkOPALESCENCE® from Ultradent Products, Inc. in South Jordan, Utah. Otherbleaching agents such as peroxyacetic acid (CH₃C═OO—OH) and sodiumperborate, are also known in the medical, dental and cosmetic arts.

Patients who have desired to have their teeth whitened have typicallydone so by applying a bleaching composition to the teeth by means of adental tray for repeated treatments, or they have had to submit toconventional in-office bleaching techniques that required from 4 to 10visits to the dental office before clinically significant results wereachieved. Clinically significant results are quantifiable such as bymeasuring gray scale, L*, and as to yellowness or blueness, b*, in theCIE® system of color measurement or by equivalent methods.

Patients expecting their teeth to be whitened by such bleachingtreatments may be pleased to have their stains removed, however, a moreideal aesthetic objective of whiter teeth may still not be adequatelyachieved. The removal of stains and discolorations sometimes reveal thatthe stains camouflaged teeth which are excessively translucent.Depending on the degree of translucency, the teeth may be revealed to beoverly grey or even have portions which appear to be more transparentthan is desired.

Brushing teeth with toothpaste does not address the problem ofexcessively translucent teeth. Brushing teeth with toothpastes orpolishes is also less effective for whitening teeth compared to theapplication of bleaching treatments. Tooth brushing is less effectivefor whitening teeth as brushing teeth only cleans the external surfaceof the teeth while bleaching addresses internal stains in the teeth.

From the foregoing, it will be appreciated that what is needed in theart are compositions and methods for opacifying and decreasing thetransparency of teeth.

It will also be appreciated that what is also needed are methods andcompositions for opacifying teeth and whitening teeth without causingteeth to become overly sensitized.

What are also need are compositions and methods which are able to bleachteeth while concurrently offsetting the tendency of bleaching agents tocause teeth to become overly sensitive.

BRIEF SUMMARY AND OBJECTS OF THE INVENTION

The present invention generally relates to dental whitening compositionsand methods for treating excessively translucent teeth. In addition, thepresent invention relates to bleaching compositions that result inreduced sensitivity. The present invention utilizes potassium nitrate(KNO₃) dispersed within a carrier as an opacifying agent to reduce thetendency of some teeth to appear grey or translucent. Potassium nitratecan act as an opacifying agent either alone or in combination with ableaching agent. Because potassium nitrate also has desensitizing oranesthetic properties, it can desensitize and/or opacify when used inconjunction with a bleaching agent, or it can be applied separately todesensitize teeth after bleaching has occurred.

In addition to potassium nitrate, other dental agents may be dispersedin the carrier. In one embodiment, the whitening compositions willinclude a bleaching agent, such as carbamide peroxide, which can alsoact as a disinfectant. Alternatively, or in addition to including ableaching agent, the whitening compositions may include one or moreother dental agents, such as anticariogenic agents for reinforcing teethagainst tooth decay or antimicrobial agents for treating gum diseases.The most commonly used anticariogenic agents include fluoride salts,such as stannous or sodium fluoride, which can also impartantidemineralization or even remineralization properties to the toothwhitening compositions. Examples of preferred antimicrobial agentsinclude chlorohexidine, tetracycline, cetyl pyridinium chloride,benzalkonium chloride, cetyl pyridinium bromide, methyl benzoate, andpropyl benzoate.

The compositions are preferably substantially free of abrasives, as thecompositions are typically not scrubbed onto teeth. When using abrasivetoothpastes, people typically brush for less than 60 seconds, which isnot enough time for the active ingredients to perform their intendedactivity. On the other hand, scrubbing teeth with an abrasive materialfor an extended period of time can be harmful in some cases. Therefore,in order to allow for extended application, the inventive compositionswill preferably not include substantial quantities of an abrasive.

The compositions are preferably used with a dental tray that isthin-walled, flexible and lightweight. Such trays can be held by thedental composition in position adjacent to the person's tooth surfacesto be treated. The preferred dental tray should be adapted for maximumcomfort and will exert little if any significant mechanical pressureonto the person's teeth or gums. Accordingly, when used with a tray, thedental whitening compositions will preferably be sufficiently sticky,viscous and resistant to dilution by saliva such that they can act as aglue and reliably adhere and retain the dental tray over the person'steeth for varying time durations. Nevertheless, although such dentaltrays are preferred, any conventional dental trays may also be utilized.In addition, the inventive dental compositions can be applied directlyto a person's teeth without a tray. In such cases, higher concentrationsof the dental agent(s) will preferably be used in order to speed up thedesired action or results of the dental agent(s).

Any component other than the active dental agents, such as the potassiumnitrate, bleaching agent, antimicrobial agent, and anticariogenic agent,shall comprise the “carrier”. In the case where the dental compositionis sticky and viscous, the carrier will include a sticky matrix materialformed by combining a sufficient quantity of a tackifying agent, such ascarboxypolymethylene, with a solvent, such as glycerin, polyethyleneglycol, or water. Although the carrier is preferably formed by combininga tackifying agent and a solvent, the carrier may comprise a solventwithout a tackifying agent in some embodiments. Preferred compositions,as described hereinbelow, are relatively sticky and glue-like to enablea preferred dental tray to be held and retained against a person'steeth. Preferred carriers are preferably safe for oral use, do notreadily dissolve in saliva, and do not react with the tooth opacifyingagent.

In addition to carboxypolymethylene, examples of other suitabletackifying agents, or thickening agents that can assist other tackifyingagents, include xanthan gum, talha gum, tragacanth gum,carboxymethylcellulose, locust bean gum, guar gum, Irish moss gum,ghatti gum, furcelleran gum, carrageenan gum, arabic gum, alginic acidgum, agar gum, alginate gum, PEMULEN®, a proprietary compound of B. F.Goodrich, POLYOX®, a mixture of polyethylene oxides having a molecularweight of 100,000-8,000,000 and available from Union Carbide, or anycompositional or chemical equivalents of the foregoing. PEMULEN® is apropriety formula that includes a significant quantity of a polyacryliccopolymer that has a slightly hydrophobic end and a strongly hydrophilicend.

In addition to glycerin, many other polyols may serve as suitablesolvents. The solvent may also be water alone or in combination with apolyol. Glycerin is a preferred solvent as it works well in forming asticky gel with carboxypolymethylene. Glycerin also provides some flavorenhancement. A few possible substitutes for glycerin include propyleneglycols, polypropylene glycol, polyethylene glycols, eryrthritol,sorbitol, mannitol, other polyols, and the like. In some embodimentspolyols such as glycerin, polyethylene glycols, polypropylene glycol,propylene glycol, and sorbitol may also be used without a tackifyingagent.

As indicated hereinabove, one currently preferred sticky matrix materialincludes a mixture of carboxypolymethylene together and other suitableadmixtures. The term “carboxypolymethylene” is used to denote a broadcategory of polymers, particularly copolymers of acrylic acid andpolyallyl sucrose. Because carboxypolymethylene that has not beencompletely neutralized includes carboxylic acid groups or moieties,carboxypolymethylene can be classified as a weak acid. When dispersed inwater, carboxypolymethylene can have a pH as low as about 2.5.

Because highly acidic compositions can etch teeth, it is generallypreferable to adjust the pH of dental compositions that includecarboxypolymethylene or other acids to make them less acidic.Accordingly, it is preferable to adjust the pH of compositions thatinclude carboxypolymethylene to within a range from about 4 to about 9,more preferably to within a range from about 5 to about 7. Because it iscontemplated that the carboxypolymethylene used in the matrix materialand the compositions of the present invention will be mixed with a baseto raise the pH of the resulting dental composition, the term“carboxypolymethylene” shall include carboxypolymethylene polymerswithin compositions at any pH.

The matrix material can include other optional components in addition tothe carboxypolymethylene in order to provide bulk and also to yield amatrix material having the desired level of stickiness. One suchadmixture is glycerin, which is easily mixed with carboxypolymethylene.Another optional component is water, as set forth above. It ispreferable to use a base in order to adjust the pH of the matrixmaterial. Preferred bases can include inorganic bases such as sodiumhydroxide or ammonium hydroxide. Alternatively, the base may include anorganic base such as triethanolamine or other organic amines.

Since peroxides may cause irritation and also greater sensitivity inteeth for some people, the simultaneous inclusion of potassium nitratecan offset the potentially negative effects of the peroxide.Accordingly, potassium nitrate can simultaneously provide bothopacification and desensitization. Other desensitizing agents can alsobe used to desensitize teeth, including citric acid, citric acid salts,strontium chloride, and the like. Since the present invention allows forprolonged contact via the use of an appropriate tray and/or a stickycomposition, desensitizing agents in the composition are able topenetrate through the enamel.

In a preferred embodiment, the opacifying dental compositions within thescope of the present invention will be sufficiently sticky and generallyviscous such that positive pressure is needed to dispense them from thecontainer; gravity is not sufficient. Unlike conventional low-viscositycompositions such as GLY-OXIDE (manufactured by Marion Laboratories) orPROXIGEL (manufactured by Reed and Carnick according to U.S. Pat. No.3,657,413 to Rosenthal), preferred whitening compositions according tothe present invention will be packaged within a syringe, squeezabletube, or other similar positive pressure dispensing device.

An improved dental tray that is thin-walled, flexible and lightweightfor holding the dental composition adjacent to a person's teeth ispreferably used in combination with sticky and viscous dental whiteningcompositions of the present invention. The general process for preparingsuch dental trays is as follows. First, an alginate impression whichregisters all teeth surfaces plus the gingival margin is made and astone cast is made of the impression. Optional reservoirs can beprepared by building a layer of rigid material on the stone cast onspecific teeth surfaces to be treated. A dental tray is then vacuumformed from the modified cast using a thin, flexible plastic sheetmaterial. Once formed, the tray is preferably trimmed barely shy of thegingival margin on both the buccal and lingual surfaces of the person'steeth. The resulting tray provides a comfortable fit of the person'steeth with optional reservoirs or spaces located where the rigidmaterial was placed on the stone cast. The trays can optionally overlapthe gums if desired to provide contact between the dental compositionsand a person's gums. The trays of the present invention have greatlyincreased comfort and exert little or no significant mechanical pressureon a person's teeth or gums. Instead, sticky dental compositions withinthe scope of the invention can act like a glue to hold the improvedtrays in place.

The amount of tooth whitening obtained through the use of the inventivecompositions and methods is dependent primarily upon (1) the length oftime each day the tray is worn; and (2) the number of days the tray isworn. The treatment schedule may be tailored to each person's lifestyleor response to the treatment and can be performed as often as a persondesires to provide effective relief from excessively translucent teeth.It has been found that treatment during sleep is a good treatment periodsince there is less mouth activity which causes less whiteningcomposition to be pumped from the tray.

Accordingly, an object of the present invention is to providecompositions and methods for treating excessively translucent teeth.

It is another object to provide compositions for treating excessivelytranslucent teeth which can optionally include other dental agents, suchas bleaching agents, antimicrobial agents or anticariogenic agents.

It is a further object to provide compositions for bleaching teach thatinclude a desensitizing agent for offsetting the tendency of peroxidebleaching agents to make teeth more sensitive.

Finally, it is an object and feature of this invention to providecompositions for treating excessively translucent teeth that aresufficiently sticky and resistant to dilution by saliva such that theyhave the ability to adhere and retain a flexible, thin-walled dentaltray against a person's teeth, wherein the dental tray does not exertsignificant mechanical pressures onto the person's teeth or gums.

These and other objects and features of the present invention willbecome more fully apparent from the description as follows, or may belearned by the practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a stone cast of a patient's teeth with acoating being applied to selected teeth surfaces.

FIG. 2 is a perspective view of the stone cast of FIG. 1 with a dentaltray formed from the cast and trimmed below the gingival margin.

FIG. 3 is a cross-sectional view taken along line 3—3 of FIG. 2.

FIG. 3A is an enlarged close-up view taken within the section line 3A—3Aof FIG. 3.

FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. 2.

FIG. 5 is a perspective view of the opacifying composition beingdelivered from a syringe into a thin-walled, flexible dental tray.

FIG. 6 is a perspective view of a thin-walled, flexible dental trayfilled with the opacifying composition just before being positioned on apatient's upper arch.

FIG. 7 is a perspective view of a thin-walled, flexible dental trayfilled with the opacifying composition positioned on a patient's upperarch.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As summarized above, the present invention generally relates to dentalwhitening compositions and methods for treating excessively translucentteeth. At a minimum, the inventive compositions will include potassiumnitrate, which can act as either an opacifying agent, a desensitizingagent, or both. The potassium nitrate is delivered to the teeth by meansof a carrier, which includes any component other than the active dentalagent(s). In some embodiments, the inventive compositions may include ableaching agent, such as carbamide peroxide, hydrogen peroxide, and thelike, in order to further whiten a person's teeth. In such cases, thedesensitizing properties of the potassium nitrate can assist in reducingsensitivity that may be caused in some people by the bleaching agent.The compositions may also include an anticariogenic agent orantimicrobial agent. The compositions are preferably abrasiveless as thecompositions are not typically scrubbed onto a person's teeth for 60seconds or less like typical toothpastes.

In a preferred embodiment, the dental whitening compositions will beused in conjunction with a thin, flexible, comfortable-fitting dentaltray in order to hold the compositions against the person's teeth.Preferred dental trays will conform to the size and shape of a person'steeth and will exert little or no significant mechanical pressure ontothe person's teeth and/or gums. This makes them more comfortable andpleasant to use compared to conventional dental trays. Nevertheless, theinventive tooth whitening compositions may certainly be used withconventional dental trays, or with no tray at all.

In the case where a thin, flexible dental tray is used, the potassiumnitrate and optional dental agents will preferably be dispersed in acarrier containing a matrix material capable of exerting a glue-likeaction such that the whitening composition adheres and retains the trayto a person's teeth. The potassium nitrate may alternatively be placeddirectly onto the person's teeth without a tray, or by means ofconventional dental trays that are held in place by mechanical fit.

The amount of potassium nitrate that is included within the whiteningcompositions of the present invention may vary depending on whether itis desired to desensitize, opacify or both. In general, it is possibleto both desensitize and opacity at concentrations between about 0.1% toabout 10% by weight of the dental composition. Nevertheless,concentrations up to 50% can be used in some cases in order maximize thespeed and effects of the potassium nitrate, although good results arecertainly possible at lower concentrations. Thus, the inventivecompositions may preferably include potassium nitrate in a wide rangefrom about 0.1% to about 50% by weight of the whitening composition,more preferably in a range from about 1% to about 25% by weight of thewhitening composition, and most preferably in a range from about 3% toabout 10% by weight of the whitening composition.

In addition to whitening teeth by increasing the opacity or decreasingthe translucency of teeth, the potassium nitrate can act to decrease thesensitivity of teeth. The ability to decrease the sensitizing of teethis particularly beneficial when the dental whitening composition alsocontains a bleaching agent such as carbamide peroxide, which hasreportedly caused some people to experience increased sensitivity.

In a preferred embodiment, the carrier will include a tackifying agentand a solvent, which together yield a sticky matrix material, although asolvent may be used alone in some embodiments. The preferred matrixmaterial will be sufficiently sticky to enable a preferred dental trayto be held and retained against a person's teeth. Various tackifyingagents will be described hereinbelow.

Suitable sticky matrix materials are preferably safe for oral use and donot inactivate the potassium nitrate. They are preferably viscous and donot readily dissolve in saliva. One currently preferred tackifying agentused to form a sticky and viscous matrix material comprisescarboxypolymethylene. Carboxypolymethylene can be used to form aglue-like dental whitening composition that itself can act as anadhesive in holding a comfortable, non-self-retaining dental trayagainst a person's teeth. The use of carboxypolymethylene eliminates theneed to use dental trays that are self-retaining (i e., typically traysthat are rigid and which mechanically interlock over a person's teeth orgums and which are intended for use with less sticky compositions).

Carboxypolymethylene is a broad term that refers to vinyl polymershaving active carboxyl groups. Suitable carboxypolymethylenecompositions may be obtained from B. F. Goodrich Company under thetradename CARBOPOL®. Another tradename for carboxypolymethylene isCARBOMER®. In a commonly-sold form, carboxypolymethylene can have a pHas low as 2.5. As discussed below, the pH of compositions made withcarboxypolymethylene can be raised to yield compositions that are lessacidic.

The amount of carboxypolymethylene within the inventive dental whiteningcompositions can vary depending on the desired level of stickiness andalso the identities and amounts of the other components within thedental composition. In general, the dental whitening compositions of thepresent invention will preferably include carboxy-polymethylene in aconcentration in a range from about 0.5% to about 25% by weight of thedental whitening composition, more preferably in a range from about 2%to about 12% and most preferably in a range from about 3% to about 10%.Where is it desired to increase the stickiness, viscosity and resistanceto dilution to saliva, one may adjust the concentration ofcarboxypolymethylene to achieve a desired level of any or all of theseproperties. Increased stickiness assists in retaining the preferreddental trays against a person's teeth. Alternatively, compositions canbe made less adhesive and tacky if desired, particularly is applieddirectly without a dental tray.

It should be understood, however, that the actual amount ofcarboxypolymethylene is not critical for obtaining a sticky, viscousdental composition. For example, the sticky matrix material may includeother tackifying components that in combination with, or in lieu of someor all of, the carboxypolyrnethylene will yield a dental whiteningcomposition having the desired level of stickiness needed to hold apreferred, comfortable-fitting dental tray in place over a person'steeth. Other synthetic polymers and/or natural gums, proteins, or othergel-forming admixtures can be used so long as they yield a sticky dentalwhitening composition.

One currently preferred carboxypolymethylene resin is known by thetradename CARBOPOL 934P. CARBOPOL 934P is a high purity pharmaceuticalgrade of CARBOPOL 934, having an approximate molecular weight of about3,000,000. In addition to thickening and suspending, CARBOPOL 934P hasbeen used in dry tablets to impart sustained release properties.Extensive toxicity studies have been conducted on CARBOPOL 934P, and amaster file has been established with the Food and Drug Administration.It is listed as CARBOMER 934P in the National Formulary. A more recentlypreferred carboxypolymethylene is CARBOPOL 974P NF, which has morerecently surpassed CARBOPOL 934P as the carboxypolymethylene of choice.Although CARBOPOL 974P NF is similar or identical in molecular weightcompared to CARBOPOL 934P, it is purified in a way that makes it morepharmaceutically acceptable material.

It is believed that other carboxypolymethylene resins, such as CARBOPOL940, may be substituted for CARBOPOL 934P or CARBOPOL 974P NF. CARBOPOL934P and CARBOPOL 974P NF are currently preferred because they areobtainable in a pharmaceutical grade.

In order to obtain good dispersion of the carboxypolymethylene resinwithin the dental whitening composition, it is recommended that thecarboxypolymethylene be mixed with a suitable solvent before attemptingto add other components that are less compatible withcarboxypolymethylene, such as water. Examples of suitable solvents foruse with carboxypolymethylene include glycerin, other polyhydricalcohols, polyalkylene glycols and other polyols, and the like. Glycerinappears to enable larger quantities of carboxypolymethylene to bedispersed in water. It is preferable that the concentration of glycerin,polyol, or like substance utilized as a solvent in the dental whiteningcompositions be added in a range from about 15% to about 85% by weightof the dental whitening compositions, more preferably in a range fromabout 25% to about 75% by weight, and most preferably in a range fromabout 30% to about 65% by weight.

Glycerin, other polyols, and the like are inexpensive solvents that workwell in forming a sticky gel with carboxypolymethylene. The glycerinalso provides some flavor enhancement such that a bland, sweet flavor isperceived. A few possible substitutes for glycerin include propyleneglycols, polypropylene glycol, polyethylene glycols, other polyols,sorbitol, mannitol, eryrthritol, other polyhydric alcohols, stearylalcohol and other alcohols, and the like. Ethylene glycol would alsowork but is disfavored since it is toxic. In addition to acting as asolvent for the tackifying and thickening agents, hydrophilic solventssuch as glycerin, polyethylene glycols, polypropylene glycol, propyleneglycol, and sorbitol may also be used as a suitable carrier without atackifying agent.

Water may also be included as a solvent within the compositions of thepresent invention, although more carboxypolymethylene must generally beadded as water is added to maintain the same level of stickiness. Theamount of water included within the dental whitening compositions of thepresent invention is preferably in a range from about 0% to about 50% byweight of the dental whitening composition, more preferably in a rangefrom about 1% to about 45% by weight and most preferably in a range fromabout 2% to about 40% by weight. It will be appreciated that the totalquantity of water in the dental whitening composition may come fromdifferent sources. For instance, some constituents such as dental agentsand bases discussed below may come as aqueous solutions.

Because carboxypolymethylene is a polycarboxylic acid, it tends to lowerthe pH of the resulting dental whitening compositions significantly,down to a pH of about 2.5 in some cases. It appears, based upon clinicaland in vitro testing, that dental whitening compositions with a pH belowabout 5 are able to etch enamel. To avoid etching enamel, it ispreferable to add a neutralizing agent, or more specifically, a base inorder to raise the pH of the inventive dental whitening compositions towithin a pH range of about 4 to about 9. When such a composition is usedhaving a pH at the lower or upper extremes of such a range, the exposureperiod is preferably relatively brief. Accordingly, the pH is preferablyadjusted to within a range from about 5 to about 8 and most preferablyfrom about 6 to about 7. Inorganic and organic bases may be used, withthe use of concentrated aqueous sodium hydroxide (50% NaOH in water)being one currently preferred embodiment. In addition to sodiumhydroxides other inorganic bases may be used such as potassium hydroxideand ammonium hydroxide. Examples of suitable organic bases include alkylamines such as triethanolamine, di-isopropanol amine and other similaramines. The amount of neutralizing agent or base to be included willgenerally depend on the desired pH and the amount ofcarboxypolymethylene in the dental whitening composition. Accordingly,neutralizing agents or bases are preferably included in a range fromabout 1% to about 12% by weight of the dental whitening composition,more preferably in a range from about 2% to about 8% by weight and mostpreferably in a range from about 3% to about 7% by weight.

The term “carboxypolymethylene” shall be understood to includecarboxypolymethylene resins regardless of the pH of the overall dentalcomposition. In other words, the term “carboxypolymethylene” broadlyincludes resins that have been mixed with a base to raise the pH of thecompositions. Moreover, he term “carboxypolymethylene” shall broadlyinclude carboxypolymethylene resins that have reacted with, formedcomplexes with, or otherwise been altered in any way by other componentswithin the dental whitening compositions of the present invention solong as the carboxypolymethylene is able to impart the desired level ofstickiness and viscosity to the final dental whitening composition incombination with the other components within the dental whiteningcomposition.

In addition to carboxypolymethylene, examples of other suitabletackifying and thickening agents include gums such as xanthan gum, talhagum, tragacanth gum, locust bean gum, guar gum, Irish moss gum, ghattigum, furcelleran gum, carrageenan gum, arabic gum, alginic acid gum,agar gum, alginate gum. Another suitable tackifying agent is sold asPEMULEN®, a proprietary compound from B. F. Goodrich, or a compositionalor chemical equivalent thereof. PEMULEN® includes a significant quantityof a polyacrylic copolymer that has a slightly hydrophobic end and astrongly hydrophilic end. Additional examples of suitable tackifyingagents include polyethylene oxides such as POLYOX® sold by UnionCarbide. These tackifying agents may be present in the same ranges asdiscussed above in relation to carboxypolymethylene.

It is also preferable to utilize a bleaching agent to enable thewhitening composition to simultaneously bleach and opacify the teeth.Examples of suitable bleaching agents include hydrogen peroxide,carbamide peroxide, benzoyl peroxide, glyceryl peroxide and sodiumperborate. A significant advantage of using potassium nitrate as anopacifying agent in combination with a bleaching agent in a toothwhitening composition is that the potassium nitrate simultaneouslydecreases the sensitivity of the teeth that may result from the use ofthe bleaching agent. The bleaching agents are preferably included in arange from about 0.5% to about 50% by weight of the dental whiteningcomposition, more preferably in a range from about 1% to about 30% byweight and most preferably in a range from about 3% to about 20% byweight.

In order to preserve the stability of the dental whitening compositions,particularly when bleaching agents are included, it is often preferableto include an ion scavenger such as EDTA and salts of EDTA such asedetate disodium, oxine EDTA, calcium disodium EDTA, and others.Additionally, ion scavengers such as citric acid, succinic acid, adipicacid, nitrates and phosphates of tin and any other commonly-usedchelating agents may be used. Ion scavengers are preferably included inan amount in a range from about 0% to about 1% by weight of the dentalwhitening composition, more preferably in a range from about 0.03% toabout 0.5% by weight and most preferably in a range from about 0.05% toabout 0.2% by weight.

It may also be preferable to include other active dental agents toprovide other types of dental and/or gum treatment. For example, inconjunction with dental desensitization and/or opacification, it may bedesired to provide an anticariogenic treatment. Preferred anticariogenicand antidemineralizing agents include fluoride salts, more particularlysodium monofluorophosphate, sodium fluoride, and stannous fluoride.Depending on the level of fluoride treatment desired, and depending onwhether or not a composition is “over-the-counter” or “by prescription”,the fluoride will be included in a range from about 0% to about 1% byweight of the dental whitening composition, more preferably in a rangefrom about 0.1% to about 0.5% by weight.

Antimicrobial agents, e.g., for fighting gum disease, may be included inconjunction with the potassium nitrate or other opacifying agent.Examples of useful antimicrobial agents include chlorohexidine,tetracycline, cetyl pyridinium chloride, benzalkonium chloride, cetylpyridinium bromide, methyl benzoate, and propyl benzoate. Theantimicrobial agents are preferably included in an amount in a rangefrom about 0% to about 15% with the dental whitening composition, morepreferably in a range from about 1% to about 5% by weight.

As indicated hereinabove, the dental whitening compositions of thepresent invention preferably do not include an abrasive. Abrasives onlyexternally treat a tooth; however, it is believed that opacification ofa tooth is achieved by the action of the potassium nitrate internallywithin a tooth. Not only are abrasives unnecessary but inclusion ofabrasives in the composition may be undesirable in preferred embodimentswhere it is desired for the whitening composition to remain on the teethfor an extended period of time (i.e., greater than about 3 minutes). Itis common experience that toothpastes become quickly diluted by salivaand will not persist in a paste-like form for more than a short periodof time (i.e., for more than about a minute).

Other suitable tooth desensitizing agents that may be used in additionto potassium nitrate according to the present invention include citricacid, citric acid salts, strontium chloride, and the like, as well asother desensitizing agents known in the art. The amount of desensitizingagent included within the dental whitening compositions of the presentinvention may vary according to the concentration of the potassiumnitrates, the desired strength and intended treatment times.Accordingly, if included at all, the other desensitizing agents willpreferably be included in an amount in a range from about 0.1% to about10% by weight of the dental desensitizing composition, more preferablyin a range from about 1 to about 7% by weight.

One currently preferred method of dispensing sticky and viscous dentalwhitening compositions within the scope of the present invention is bymeans of a syringe. Squeezable tubes and other similar dispensingdevices may also be used to dispense the compositions. Upon dispensing,the dental whitening compositions are sufficiently viscous that they donot easily settle or spread once dispensed, but will generally remain asa single extruded strand or bead of dental whitening composition.Nevertheless, bottles, tubes or other dispensing means known in the artmay be used, particularly where the whitening composition has lowerviscosity, low stickiness, and does not include a thickening agent.

It is currently preferred to provide a unit dose of the dental whiteningcompositions in a syringe or similar dispensing device. In this way, theperson can load the precise amount of dental whitening composition ontothe dental tray for each treatment period. By using such dispensingdevices, the dentist is also able to monitor how many doses the personhas received and used.

Although not required, sticky and viscous dental whitening compositionsof the present invention are preferably used to treat a person's teethin conjunction with dental trays that exert little or no significantmechanical pressure onto a person's teeth and gums. The result is a morecomfortable and pleasant feeling dental tray, unlike prior art dentaltrays which are generally rigid and/or thick-walled such that they exertsufficient mechanical pressures onto the teeth and/or gums to be“self-retaining”. In some embodiments, however, the whiteningcompositions can be applied directly to the person's teeth without adental tray, or a less viscous and sticky whitening compositionaccording to the invention may be used in conjunction withself-retaining trays known in the art.

In the general process for preparing preferred dental trays according tothe present invention, an alginate impression is made which registersall teeth surfaces plus the gingival margin. Thereafter, a stone cast ismade of the impression. Excess stone can be trimmed away for easymanipulation and forming the dental tray.

Reference is now made to FIGS. 1-4. In a preferred method for forming adental tray, one or more reservoirs can be formed in the resultantdental tray by applying a thin coating 10 of a rigid material to thestone cast 12 corresponding to teeth where it is desired to provide moreof the dental whitening composition. As depicted in FIG. 1, the coating10 may be applied using a brush tipped applicator 14. The coating mayalso be light curable for convenience. In those instances where thedental tray is to be trimmed below the gingival margin, the coatingmaterial will preferably be applied in a manner that is kept at adistance greater than about 1 mm from the gingival line 16, morepreferably in a range from about 1.25 to about 1.5 mm from the gingivalline 16.

The finished coating will have a thickness corresponding to the desiredreservoir depth, which will commonly be about 0.5 mm. It is generallypreferred that the rigid coating material not be applied over the stonecast corresponding to the incisal edges 18 and occlusal edges 20 of theperson's teeth. This because it is preferable for the incisal edges andocclusal edges of the person's actual teeth to contact the finished trayin order to prevent or reduce vertical movement of the tray during use,which movement could act as a pump that could express the dentalwhitening composition from the tray and result in the intake of salivawithin the dental tray.

A dental tray 22 is then vacuum formed from the stone cast usingconventional techniques. The dental tray 22 is preferably constructed ofa soft transparent vinyl material preferably having a preformedthickness in a range from about 0.2 mm to about 1.5 mm, more preferablyin a range from about 0.25 mm to about 1 mm. Soft materials yield dentaltrays that are more comfortable for the patient to wear. It will beappreciated that the final tray thickness may vary depending on thetechnique used to prepare the tray, as well as the size and shape of theperson's teeth. Patients suspected of being breuxers or hard biters mayrequire either a thicker or a harder material. Of course, patientsshould be counselled not to eat with trays in place or to bite firmlyinto them.

Once formed, the dental tray 22 is preferably trimmed barely shy of thegingival margin 16 of the person's teeth on both the buccal and lingualsurfaces for maximum comfort. Enough tray material should be left toassure that the teeth will be covered to within about ¼ mm to about ⅓ mmof the gingival border upon finishing and beveling of the trayperiphery. It is also generally preferred to scallop up and around theinterdental papilla so that the finished tray does not cover them. Thetray edges are preferably smoothed so that the lip and tongue will notfeel an edge prominence. Slight adjustments to the tray may be made bycarefully heating and stretching the tray material.

Reference is now made to FIGS. 5-7. FIG. 5 depicts the dental whiteningcomposition 40 being deposited into a dental tray 50 from a syringe 60.FIG. 6 depicts dental tray 50 being inserted onto an arch 70 in apatient's mouth. FIG. 7 depicts dental tray 50 in position on the teethof arch 70. The dental composition may be deposited throughout thedental tray to contact the entire arch or may be deposited within aportion of the tray to only contact a portion of the arch. Additionally,the dental tray may be configured to only contact a portion of an archor only a single tooth. While depositing the dental whiteningcomposition into dental tray 50 as shown in FIG. 5 is the preferredmethod, the dental whitening composition may also alternatively bedeposited directly onto the teeth and then tray 50 may be positioned onthe teeth of arch 70.

From practice, it has been found that patients may experience less toothdiscomfort from tray pressures when using a tray with reservoirs builtinto the tray as described above. It is currently believed this is dueto the fact that the teeth are not held as firmly by the tray, so“orthodontic” pressures experienced by teeth from tray discrepancies areminimized. The use of thin, soft tray materials minimize mechanicalforces applied to teeth or gums compared to the harder or thickerplastics known in the art. Reservoirs, of course, can provide more ofthe dental whitening composition against the person's teeth and can alsoassist in seating the dental tray over the person's teeth.

Although the aforementioned thin, flexible dental trays are preferredwhen treating a person's teeth, it may be preferable in some cases toallow the dental tray to overlap the person's gums in the case wheredental agents are included to fight gum diseases. Of course, to theextent that the dental whitening compositions do not irritate the gums,the dental trays can always be constructed to overlap the gums.

Nevertheless, it has been found that where it is desired to treat aperson's teeth rather than the gums, it is generally more comfortablefor the patient if the dental tray has been trimmed to or below thegingival margin. Even in those cases where the dental trays will overlapthe person's gums, the dental trays of the present invention preferablywill not exert significant mechanical pressure onto the person's gums.

Because the preferred dental trays described herein can be made to exertlittle or no mechanical pressure onto a person's teeth and gums, it willbe important in such cases for the inventive dental whiteningcompositions to be able to act like a glue to reliably adhere and retainthe dental tray over a person's teeth for the desired length oftreatment. Accordingly, the dental whitening compositions willpreferably have a stickiness such that they can reliably adhere andretain a dental tray over a person's teeth for at least about one hourwithout significant mechanical pressure from the dental tray, morepreferably for at least about two hours, and most preferably for atleast about four hours. Nevertheless, while the foregoing time durationsare given in order to provide an accurate measurement of the stickinessof the dental whitening compositions of the present invention, theyshould not be taken to be a limitation as to the actual length of timethat the patient may wish to use the inventive dental whiteningcompositions. While a given dental whitening composition may be able toretain the dental tray against a person's teeth for, e.g., 10 hours ormore, that composition could certainly be used within the scope of thepresent invention for any desired time period, such as for 15 minutes,one hour, or any desired time duration.

The dental whitening compositions of the present invention may be usedat any time and for any duration by a person that desires to make his orher teeth less translucent and more white. Although the dental whiteningcompositions of the present invention facilitate the use of flexible,thin-walled dental trays that are more comfortable to use compared toprior dental trays, the insertion of any dental tray within a person'smouth will cause some alteration of behavior and diminution of thefreedom to use one's mouth. Therefore, in order to maximize treatmenttime and reduce the inconvenience of having a dental tray lodged withina person's mouth, it is recommended to use the dental trays at nightduring a person's sleep.

Although long exposure times may be desired in some cases, it has beenfound that optimal results may be achieved from cyclic exposure periodsinvolving repeated exposures over several days. For example, thetreatment regime may alternatively entail exposure for a period of timesuch as an hour without further exposure until the subsequent day. Forday use, it is recommended that the whitening compositions be appliedfor about 1 to 3 hours. The length of the treatment period during nightuse may vary with the sleep pattern of the particular person and mayaccordingly be between about 5 to 9 hours.

Although it is recommended that the dental whitening compositions of thepresent invention may be applied and allowed to contact teeth forseveral hours, much shorter periods of time, even as brief as 3 minutes,result in some degree of opacification. Obviously when a patient's teethare exposed to the whitening compositions for only brief periods such asabout 5 to 15 minutes, the rate of opacification will usually be muchslower than when the exposure time is an hour or several hours.

The use of dental trays is preferred as extended contact between thecomposition and the teeth is enabled through the support and protectionof the tray. However, other methods of contacting teeth with theinventive dental whitening composition are also within the scope of theinvention in addition to the use of the dental whitening compositionwith a dental tray. For example, the dental whitening composition can bemerely deposited onto a tooth or several teeth during one or more dentaloffice visits. In such an application, the dental whitening compositionis sufficiently sticky and viscous to stay in contact with the tooth orteeth to be whitened for a period of time of at least about threeminutes without significant agitation of the composition against thetooth or teeth.

The dental whitening composition may be used with rubber dams and resinbarriers, particularly when the composition includes bleaching agents.More particularly, the dental whitening composition may be used incombination with rubber dams and resin barriers when the method involveshigh concentrations of bleaching agents or rapid whitening whichinvolves directing heat or light to the bleaching composition. Examplesof such rubber dams and resin barriers are disclosed in U.S. patentapplication Ser. No. 08/802,674, entitled “Polymerizable IsolationBarriers and Methods for Forming and Using such Barriers” and filed onFeb. 19, 1997, which is hereby incorporated by reference. The preferredresin barrier is sold by Ultradent Products, Inc. under the markOPALDAM™. The preferred rubber dam is sold under the mark DERMADAM™ andis preferably used in conjunction with caulking and putty materials soldunder the mark ORASEAL®, all of which are available from UltradentProducts, Inc.

In order to more clearly illustrate the parameters of the inventivedental whitening compositions within the scope of the present invention,the following examples are presented. The following examples areintended to be exemplary and should not be viewed as limiting to thescope of the invention.

EXAMPLE 1

A whitening composition within the scope of the present invention wasprepared by combining the following ingredients in the followingproportions, measured as percentage by weight of the whiteningcomposition:

CARBOPOL 974P NF 6.8% Glycerin 48.45% Polyethylene glycol 300 5.5% Water20.0% Sodium hydroxide (50%) 5.4% KNO₃ 3.0% Carbamide peroxide 10.5%Disodium EDTA 0.1% NaF 0.25%

The CARBOPOL 974P NF was obtained from B. F. Goodrich Company inCleveland, Ohio. The CARBOPOL 974P NF was first combined with theglycerin and polyethylene glycol 300 then mixed with the water. Mixingglycerin and polyethylene glycol 300 within the CARBOPOL 974P NF enabledit to be more easily mixed with the water. The KNO₃, carbamide peroxideand disodium EDTA were added to the mixture, after which the sodiumhydroxide was blended into the homogeneous composition in order to raisethe pH to an acceptable level. The sodium fluoride was then added. Theresulting dental whitening composition had opacifying, bleaching,desensitizing and anticariogenic properties, and was sufficiently stickythat it could reliably hold and maintain a dental tray against aperson's teeth without significant mechanical pressure being exerted bythe tray onto a person's teeth and gums.

EXAMPLE 2

A sticky opacifying dental whitening composition within the scope of thepresent invention was made according to the procedure of Example 1,except that more KNO₃ was included and slightly less glycerin was addedsuch that the remaining components were combined in the followingamounts as a percentage by weight of the composition:

CARBOPOL 974P NF 6.8% Glycerin 46.45% Polyethylene glycol 300 5.5% Water20.0% Sodium hydroxide (50%) 5.4% KNO₃ 5.0% Carbamide peroxide 10.5%Disodium EDTA 0.1% NaF 0.25%

The foregoing procedure resulted in a dental whitening composition. Theresulting dental whitening composition had more opacifying anddesensitizing capability than the composition of Example 1. Thecomposition was sufficiently sticky that it could reliably hold andmaintain a dental tray against a person's teeth without significantmechanical pressure on the patient's teeth and gums as in Example 1.

EXAMPLE 3

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

CARBOPOL 974P NF 6.8% Glycerin 40.55% Polyethylene glycol 300 5.5% Water21.0% Sodium hydroxide (50%) 5.4% KNO₃ 5.0% Carbamide peroxide 15.5%Disodium EDTA 0.1% NaF 0.15%

The foregoing procedure results in a sticky dental whitening compositionhaving more opacifying, desensitizing and bleaching capability than thecomposition of Example 1, but with slightly less anticariogeniccapability.

EXAMPLE 4

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theglycerin is replaced by propylene glycol. The ingredients are combinedin the following concentrations by weight percent:

CARBOPOL 974P NF 6.8% Propylene Glycol 48.45% Polyethylene glycol 3005.5% Water 20.0% Sodium hydroxide (50%) 5.4% KNO₃ 3.0% Carbamideperoxide 10.5% Disodium EDTA 0.1% NaF 0.25%

The foregoing procedure results in a sticky dental whitening compositioncapable of holding and maintaining a dental tray against a person'steeth in essentially the same manner as in Example 1. The opacifying,desensitizing, bleaching and anticariogenic capabilities are similar tothose using the composition of Example 1.

EXAMPLE 5

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentration by weightpercent:

CARBOPOL 974P NF 6.8% Glycerin 68.85% Sodium hydroxide (50%) 5.4% KNO₃8.0% Carbamide peroxide 10.5% Disodium EDTA 0.2% NaF 0.25%

The foregoing procedure results in a sticky dental whitening compositioncapable of holding and maintaining a dental tray against a person'steeth in essentially the same manner as in Example 1. The compositionhas a higher level of opacifying activity and desensitizing capabilitycompared to the compositions of Examples 1-4.

EXAMPLE 6

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Polyethylene glycol 300 5.5% Propylene Glycol 45.2% Water 30.0%PEMULEN ® TR-1 NF 6.8% Sodium hydroxide (50%) 5.4% KNO₃ 3.0% Hydrogenperoxide (30%) 4.0% Citric acid 0.1%

The foregoing procedure results in a sticky dental whitening compositionhaving a lower viscosity compared with the composition in Example 1. Thecomposition has a similar level of opacifying capability and slightlymore effective bleaching capability than the composition of Example 1.

EXAMPLE 7

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

CARBOPOL 974P NF  6.8% Glycerin 57.35% Polyethylene glycol 300  5.5%Propylene glycol 20% Triethanolamine  8.0% KNO₃  1.0% Sodium perborate21.0% Disodium EDTA  0.1% Sodium monofluorophosphate  0.25%

The foregoing procedure results in a sticky dental whitening compositionhaving opacifying capability and desensitizing capability in a basicenvironment.

EXAMPLE 8

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

CARBOPOL 974P NF 6.8% Glycerin 59.2% Polyethylene glycol 300 5.5% Water20.0% Sodium hydroxide (50%) 5.4% KNO₃ 3.0% Disodium EDTA 0.1%

The foregoing procedure results in a sticky dental whitening compositioncapable of holding and maintaining a dental tray against a person'steeth in essentially the same manner as in Example 1. The compositionhas desensitizing and opacifying capabilities which are similar to thoseof the composition of Example 1.

EXAMPLE 9

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Glycerin 50.8% Distilled Water 30% Xanthan gum  1.0% KN0₃  3.0%Carbamide peroxide 15.0% Disodium EDTA  0.2%

The foregoing procedure results in a dental whitening composition havingsimilar opacifying and desensitizing capabilities compared to thecomposition of Example 1. The composition is less sticky than thecomposition of Example 1 and has greater bleaching capability.

EXAMPLE 10

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Glycerin 87.0% KNO₃ 3.0% Carbamide peroxide 15.0%

The foregoing procedure results in a dental whitening composition havingsimilar opacifying and desensitizing capabilities compared to thecomposition of Example 1. However, the composition is less sticky thanthe composition of Example 1 and has greater bleaching capability.

EXAMPLE 11

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Glycerin 97.0% KNO₃ 3.0%

The foregoing procedure results in a dental whitening composition havingsimilar opacifying and desensitizing capabilities compared to thecomposition of Example 1. The composition has a lower viscosity and isless sticky than the composition of Example 1.

EXAMPLE 12

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Propylene glycol 40.0% Polyethylene glycol 8000  5.0% Polyethyleneglycol 600 27.0% Water  7% KNO₃  6.0% hydrogen peroxide (30%) 15.0%

The foregoing procedure results in a dental whitening composition thatis less sticky and has a lower viscosity than the composition ofExample 1. The composition is able to impart a higher degree ofopacification, desensitization, and bleaching compared to thecomposition of Example 1.

EXAMPLE 13

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Glycerin 30.0% Propylene glycol 300 30.0% KNO₃ 5.0% Sodium perborate35.0%

The foregoing procedure results in a dental whitening composition thatis less sticky and has a lower viscosity than the composition ofExample 1. The composition is able to impart a higher degree ofopacification, desensitization, and bleaching compared to thecomposition of Example 1.

EXAMPLE 14

A dental whitening composition within the scope of the present inventionis made according to the procedure of Example 1, except that theingredients are combined in the following concentrations by weightpercent:

Propylene glycol 47.5% Polyethylene glycol 300 30.0% KNO₃ 2.5% Carbamideperoxide 20.0%

The foregoing procedure results in a dental whitening composition thatis less sticky and has a lower viscosity than the composition ofExample 1. The composition has about the same opacifying anddesensitizing capability but greater bleaching capability compared tothe composition of Example 1.

EXAMPLE 15

To any of the foregoing dental whitening compositions is added one ormore of the following antimicrobial agents for treatment of a patient'sgums: chlorohexidine, tetracycline, cetyl pyridinium chloride,benzalkonium chloride, cetyl pyridinium bromide, methyl benzoate, andpropyl benzoate. These compositions are preferably used in conjunctionwith a thin walled, flexible dental tray that overlaps the person's gumsin order for the dental whitening compositions to contact the gums beingtreated.

EXAMPLE 16

To any of the foregoing dental whitening compositions which include ableaching agent and do not include a bleaching agent stabilizer, one ofthe following chelating agents may be added: EDTA, monosodium EDTA,citric acid, succinic acid, and adipic acid.

From the foregoing, it will be appreciated that the present inventionprovides compositions and methods for treating excessively translucentteeth to opacify and thereby whiten the teeth.

The present invention also provides dental whitening compositions fortreating excessively translucent teeth which optionally include otherdental agents for treating teeth and/or gums, such as bleaching,antimicrobial or anticariogenic agents.

The present invention also provides dental whitening compositions forbleaching teeth while relieving excessive sensitivity of a person'steeth.

Finally, the present invention provides compositions for treatingexcessively translucent teeth that can be sufficiently sticky andresistant to dilution by saliva such that they have the ability toadhere and retain a flexible, thin-walled dental tray against a person'steeth, wherein the dental tray does not exert significant mechanicalpressures onto the person's teeth or gums.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed and desired to be secured by United States LettersPatent is:
 1. A stable, one-part sticky dental bleaching composition foruse with a dental tray comprising: a peroxide dental bleaching agentincluded in an amount so as to bleach teeth; potassium nitrate includedin an amount so as to reduce tooth sensitivity that may be caused by theperoxide dental bleaching agent when left in contact with a person'steeth for a time sufficient to cause bleaching of the teeth; and acarrier including a solvent and a tackifying agent selected from thegroup consisting of carboxypolymethylene, polyacrylic copolymers, gums,polyethylene oxides, proteins, and mixtures thereof, the dentalcomposition having a stickiness so that the dental composition iscapable of adhering and retaining a dental tray that is designed not toexert significant mechanical pressure onto the person's teeth and gumsover a person's teeth for a prescribed time period.
 2. A stable,one-part sticky dental bleaching composition as defined in claim 1,wherein the potassium nitrate is included in an amount in a range fromabout 0.1% to about 50% by weight of the dental bleaching composition.3. A stable, one-part sticky dental bleaching composition as defined inclaim 1, wherein the potassium nitrate is included in amount in rangefrom about 3% to about 10% by weight of the dental bleachingcomposition.
 4. A stable, one-part sticky dental bleaching compositionas defined in claim 1, wherein the tackifying agent includescarboxypolymethylene included in an amount in a range from about 0.5% toabout 20% by weight of the dental bleaching composition.
 5. A stable,one-part sticky dental bleaching composition as defined in claim 4,wherein the carboxypolymethylene is included in an amount in a rangefrom about 2% to about 12% by weight of the dental bleachingcomposition.
 6. A stable, one-part sticky dental bleaching compositionas defined in claim 1, wherein the solvent includes water in an amountup to about 50% by weight of the dental bleaching composition.
 7. Astable, one-part sticky dental bleaching composition as defined in claim1, wherein the solvent includes a polyol.
 8. A stable, one-part stickydental bleaching composition as defined in claim 7, wherein the polyolis selected from the group consisting of glycerin, propylene glycol,polypropylene glycol, polyethylene glycol, eryrthritol, sorbitol,mannitol, and mixtures thereof.
 9. A stable, one-part sticky dentalbleaching composition as defined in claim 1, further including a basepresent in an amount so that the dental composition has a pH in a rangefrom about 4 to about
 9. 10. A stable, one-part sticky dental bleachingcomposition as defined in claim 1, further including at least oneantimicrobial agent selected from the group consisting of chlorhexadine,tetracycline, cetyl pyridinium chloride, benzalkonium chloride, cetylpyridinium bromide, methyl benzoate, and propyl benzoate.
 11. A stable,one-part sticky dental bleaching composition as defined in claim 1,further including at least one anticariogenic agent selected from thegroup consisting of sodium monofluorophosphate, sodium fluoride, andstannous fluoride.
 12. A stable, one-part sticky dental bleachingcomposition as defined in claim 1, wherein the dental bleachingcomposition is pre-loaded within a syringe.
 13. A stable, one-partsticky dental bleaching composition for use with a dental traycomprising: a peroxide dental bleaching agent included in an amount soas to bleach teeth; potassium nitrate included in an amount so as toreduce tooth sensitivity that may be caused by the dental bleachingagent when left in contact with a person's teeth for a time sufficientto cause bleaching of the teeth; a bleaching agent stabilizer; and acarrier including a tackifying agent selected from the group consistingof carboxypolymethylene, polyacrylic copolymers, gums, polyethyleneoxides, proteins, and mixtures thereof, the dental composition having astickiness so that the dental composition is capable of adhering andretaining a dental tray that is designed not to exert significantmechanical pressure onto the person's teeth and gums over a person'steeth for a prescribed time period.
 14. A method for bleaching teethcomprising: (a) providing a dental tray configured to cover a person'steeth and hold therein a quantity of a dental bleaching composition; (b)placing a quantity of a stable, one-part desensitizing dental bleachingcomposition within the dental tray, the dental bleaching compositionincluding a peroxide dental bleaching agent included in an amount so asto bleach teeth, potassium nitrate included in an amount so as to reducetooth sensitivity that may be caused by the dental bleaching agent whenleft in contact with a person's teeth for a time sufficient to causesignificant bleaching of the teeth, and a carrier including a tackifyingagent selected from the group consisting of carboxypolymethylene,polyacrylic copolymers, gums, polyethylene oxides, proteins, andmixtures thereof, (c) positioning the dental tray over the person'steeth for a period of time sufficient to cause bleaching of the teeth;and (d) removing the dental tray from the person's teeth.
 15. A methodas defined in claim 14, wherein the potassium nitrate is included in anamount in a range from about 0.1% to about 50% by weight of the dentalbleaching composition.
 16. A stable, one-part sticky dental bleachingcomposition as defined in claim 1, further including an ion scavengerselected from the group consisting of EDTA, salts of EDTA, citric acid,succinic acid, adipic acid, tin nitrate, tin phosphate, and mixturesthereof.
 17. A stable, one-part sticky dental bleaching composition asdefined in claim 1, wherein the dental bleaching composition is free ofabrasives.
 18. A sticky dental bleaching composition as defined in claim13, wherein the bleaching agent stabilizer is selected from the groupconsisting of EDTA, salts of EDTA, citric acid, succinic acid, adipicacid, tin nitrate, tin phosphate, and mixtures thereof.
 19. A method forbleaching teeth as defined in claim 14, wherein the dental bleachingcomposition further includes an ion scavenger selected from the groupconsisting of EDTA, salts of EDTA, citric acid, succinic acid, adipicacid, tin nitrate, tin phosphate, and mixtures thereof.
 20. A method forbleaching teeth comprising: (a) providing a thin-walled, flexible dentaltray configured to cover a person's teeth and hold therein a quantity ofa dental bleaching composition, wherein the dental tray is configured tobe retained in a desired position over the person's teeth due toadhesive properties of the dental bleaching, composition rather thansolely due to mechanical fit of the dental tray; (b) placing a quantityof a stable, one-part sticky dental bleaching composition within thedental tray, the dental bleaching composition including a peroxidedental bleaching agent included in an amount so as to bleach teeth,potassium nitrate included in an amount so as to reduce toothsensitivity that may be caused by the dental bleaching agent when leftin contact with a person's teeth for a time sufficient to causebleaching of the teeth, a bleaching agent stabilizer, and a carrierincluding a tackifying agent selected from the group consisting ofcarboxypolymethylene, polyacrylic copolymers, gums, polyethylene oxides,proteins, and mixtures thereof; (c) positioning the dental tray in adesired position over the person's teeth for a period of time sufficientto bleach teeth, wherein the adhesive dental bleaching composition isprimarily responsible for retaining the dental tray in a desiredposition over the person's teeth rather than solely due to mechanicalfit of the dental tray; and (d) removing the dental tray from theperson's teeth.
 21. A method for bleaching teeth as defined in claim 20,wherein the bleaching agent stabilizer is selected from the groupconsisting of EDTA, salts of EDTA, citric acid, succinic acid, adipicacid, tin nitrate, tin phosphate, and mixtures thereof.
 22. A method forbleaching teeth as defined in claim 20, wherein the dental bleachingcomposition is free of abrasives.
 23. A sticky dental bleachingcomposition as defined in claim 13, wherein the dental bleachingcomposition is free of abrasives.
 24. A sticky dental bleachingcomposition as defined in claim 14, wherein the dental bleachingcomposition is free of abrasives.
 25. A stable, ones part sticky dentalbleaching composition as defined in claim 1, wherein the dentalbleaching agent is selected from the group consisting of aqueoushydrogen peroxide, carbamide peroxide, and mixtures thereof.
 26. Astable, one-part sticky dental bleaching composition as defined in claim1, wherein the dental bleaching agent is selected from the groupconsisting of sodium perborate, benzoyl peroxide, glyceryl peroxide, andmixtures thereof.